Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2025-12-29 @ 6:26 AM
Study NCT ID:
NCT01212666
Status:
COMPLETED
Last Update Posted:
2012-09-11
First Post:
2010-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-09', 'studyFirstSubmitDate': '2010-05-26', 'studyFirstSubmitQcDate': '2010-09-30', 'lastUpdatePostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain-score (VAS), patient standing', 'timeFrame': '2 hours postoperative', 'description': 'Pain-score messured on a Visual Analog Scale (VAS) 2 hours after adductor canal block. Patient standing. Intervention-group vs. placebo-group.'}], 'secondaryOutcomes': [{'measure': 'Total Opioid-consumption', 'timeFrame': '0-24 hours postoperative', 'description': 'ACB-group vs. placebo-group'}, {'measure': 'Postoperative Nausea and Vomiting', 'timeFrame': '0 hour postoperative', 'description': 'Levels of nausea (0-3). ACB-group vs. placebo-group'}, {'measure': 'Postoperative ondansetron consumption', 'timeFrame': 'In hospital'}, {'measure': 'Pain-score (VAS), patient at rest', 'timeFrame': '0 hours postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), patient at rest', 'timeFrame': '1 hour postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), patient at rest', 'timeFrame': '2 hours postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), patient at rest', 'timeFrame': '4 hours postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), patient at rest', 'timeFrame': '6 hours postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), patient at rest', 'timeFrame': '8 hours postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), patient at rest', 'timeFrame': '24 hours postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), patient standing', 'timeFrame': '1 hour postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), patient standing', 'timeFrame': '2 hours postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), patient standing', 'timeFrame': '4 hours postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), patient standing', 'timeFrame': '6 hours postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), patient standing', 'timeFrame': '8 hours postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), patient standing', 'timeFrame': '24 hours postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), after 5 meters of walk', 'timeFrame': '2 hours postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), after 5 meters of walk', 'timeFrame': '4 hours postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), after 5 meters of walk', 'timeFrame': '6 hours postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), after 5 meters of walk', 'timeFrame': '8 hours postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Pain-score (VAS), after 5 meters of walk', 'timeFrame': '24 hours postoperative', 'description': 'ACB-group vs. placebo'}, {'measure': 'Postoperative Nausea and Vomiting', 'timeFrame': '1 hours postoperative', 'description': 'Levels of nausea (0-3). ACB-group vs. placebo-group'}, {'measure': 'Postoperative Nausea and Vomiting', 'timeFrame': '2 hours postoperative', 'description': 'Levels of nausea (0-3). ACB-group vs. placebo-group'}, {'measure': 'Postoperative Nausea and Vomiting', 'timeFrame': '4 hours postoperative', 'description': 'Levels of nausea (0-3). ACB-group vs. placebo-group'}, {'measure': 'Postoperative Nausea and Vomiting', 'timeFrame': '6 hours postoperative', 'description': 'Levels of nausea (0-3). ACB-group vs. placebo-group'}, {'measure': 'Postoperative Nausea and Vomiting', 'timeFrame': '8 hours postoperative', 'description': 'Levels of nausea (0-3). ACB-group vs. placebo-group'}, {'measure': 'Postoperative Nausea and Vomiting', 'timeFrame': '24 hours postoperative', 'description': 'Levels of nausea (0-3). ACB-group vs. placebo-group'}, {'measure': 'Sedation', 'timeFrame': '0, hour postoperative', 'description': 'Levels of sedation (0-3). ACB-group vs. placebo'}, {'measure': 'Sedation', 'timeFrame': '1 hour postoperative', 'description': 'Levels of sedation (0-3). ACB-group vs. placebo'}, {'measure': 'Sedation', 'timeFrame': '2 hours postoperative', 'description': 'Levels of sedation (0-3). ACB-group vs. placebo'}, {'measure': 'Sedation', 'timeFrame': '4 hours postoperative', 'description': 'Levels of sedation (0-3). ACB-group vs. placebo'}, {'measure': 'Sedation', 'timeFrame': '6 hours postoperative', 'description': 'Levels of sedation (0-3). ACB-group vs. placebo'}, {'measure': 'Sedation', 'timeFrame': '8 hours postoperative', 'description': 'Levels of sedation (0-3). ACB-group vs. placebo'}, {'measure': 'Sedation', 'timeFrame': '24 hours postoperative', 'description': 'Levels of sedation (0-3). ACB-group vs. placebo'}, {'measure': 'Postoperative Nausea and Vomiting', 'timeFrame': '0 hours postoperative', 'description': 'Levels of nausea (0-3). ACB-group vs. placebo-group'}, {'measure': 'Pain (VAS) at rest, 0-24 hours postoperative (AUC)', 'timeFrame': '0-24 h postoperative', 'description': 'Pain-score messured on a Visual Analog Scale (VAS) 0-24 hours after adductor canal block (AUC). Patient at rest. Intervention-group vs. placebo-group.'}, {'measure': 'Pain (VAS), patient standing, 1-24 hours postoperative (AUC)', 'timeFrame': '1-24 hours postoperative', 'description': 'Pain-score messured on a Visual Analog Scale (VAS) 1-24 hours after adductor canal block (AUC). Patient standing. Intervention-group vs. placebo-group.'}, {'measure': 'Pain (VAS), pain after 5 meters of walk, 2-24 hours postoperative (AUC)', 'timeFrame': '2-24 hours postoperative', 'description': 'Pain-score messured on a Visual Analog Scale (VAS) 2-24 hours after adductor canal block (AUC). Pain after 5 meters of walk. Intervention-group vs. placebo-group.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adductor Canal Block (ACB)', 'Anterior Cruciate Ligament (ACL) Reconstruction', 'Saphenous nerve', 'Pain', 'Ultrasound block'], 'conditions': ['Anterior Cruciate Ligament Reconstruction']}, 'referencesModule': {'references': [{'pmid': '23549123', 'type': 'DERIVED', 'citation': 'Espelund M, Fomsgaard JS, Haraszuk J, Mathiesen O, Dahl JB. Analgesic efficacy of ultrasound-guided adductor canal blockade after arthroscopic anterior cruciate ligament reconstruction: a randomised controlled trial. Eur J Anaesthesiol. 2013 Jul;30(7):422-8. doi: 10.1097/EJA.0b013e328360bdb9.'}]}, 'descriptionModule': {'briefSummary': 'The Purpose of this study is to determine whether Adductor-Canal-Block is superior to placebo when it comes to analgetic efficacy after reconstruction of the anterior cruciate ligament.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-70 years\n* Reconstruction of Anterior Cruciate Ligament\n* Written consent\n* ASA I-II\n* BMI 19-35\n\nExclusion Criteria:\n\n* Unable to communicate in Danish\n* Allergic reactions toward drugs used in the trial\n* Pregnancy\n* Abuse of alcohol/drugs\n* Daily opioid intake\n* Infection at injection site\n* Can not be mobilised to 5 meters of walk; pre-surgery'}, 'identificationModule': {'nctId': 'NCT01212666', 'briefTitle': 'The Efficacy of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'The Effect of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction in Day Case Surgery', 'orgStudyIdInfo': {'id': 'SM1-ME-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adductor-Canal-Block, Ropivacain', 'description': '25 patients. ACB. 30 mL Ropivacain 7,5 mg/mL. Ultrasound-guided application.', 'interventionNames': ['Procedure: Ropivacain']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Adductor Canal Block, Placebo (saline)', 'description': '25 patients. ACB. 30 mL Saline. Ultrasound-guided application.', 'interventionNames': ['Procedure: Saline']}], 'interventions': [{'name': 'Ropivacain', 'type': 'PROCEDURE', 'otherNames': ['Naropin'], 'description': 'Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.', 'armGroupLabels': ['Adductor-Canal-Block, Ropivacain']}, {'name': 'Saline', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.', 'armGroupLabels': ['Adductor Canal Block, Placebo (saline)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Copenhagen', 'state': 'Glostrup', 'country': 'Denmark', 'facility': 'Department of Anaesthesiology, Glostrup University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Malene Espelund, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Glostrup University Hospital, Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Malene Espelund', 'investigatorAffiliation': 'Glostrup University Hospital, Copenhagen'}}}}